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001-es BibID:	BIBFORM107454
035-os BibID:	(cikkazonosító)36 (scopus)85084535573 (wos)000535606600002
Első szerző:	Timmers, Marjolein
Cím:	How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study / Timmers, Marjolein; van Dijck, Jeroen T. J. M.; van Wijk, Roel P. J.; Legrand, Valerie; van Veen, Ernest; Maas, Andrew I. R.; Menon, David K.; Citerio, Giuseppe; Stocchetti, Nino; Kompanje, Erwin J. O., CENTER-TBI investigators and participants
Dátum:	2020
ISSN:	1472-6939
Megjegyzések:	Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75?224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Research ethic committees European Union Health-care research CENTER-TBI Harmonization
Megjelenés:	BMC Medical Ethics. - 21 : 1 (2020), p. 1-14. -
További szerzők:	van Dijck, Jeroen T. J. M. van Wijk, Roel P. J. Legrand, Valerie van Veen, Ernest Maas, Andrew I. R. Menon, David Krishna Citerio, Giuseppe Stocchetti, Nino Kompanje, Erwin J. O. Sándor János (1966-) (orvos-epidemiológus) CENTER-TBI Participants and Investigators
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001-es BibID:	BIBFORM107355
035-os BibID:	(scopus)85132842261 (wos)000834619400012
Első szerző:	van der Vlegel, Marjolein
Cím:	Health care utilization and outcomes in older adults after Traumatic Brain Injury : a CENTER-TBI study / van der Vlegel Marjolein, Mikolic Ana, Lee Hee Quentin, Kaplan Z. L. Rana, Retel Helmrich Isabel R. A., van Veen Ernest, Andelic Nada, Steinbuechel Nicole v., Plass Anne Marie, Zeldovich Marina, Wilson Lindsay, Maas Andrew I. R., Haagsma Juanita A., Polinder Suzanne, CENTER-TBI Participants and Investigators
Dátum:	2022
ISSN:	0020-1383
Megjegyzések:	Introduction: The incidence of Traumatic Brain Injury (TBI) is increasingly common in older adults aged ?65 years, forming a growing public health problem. However, older adults are underrepresented in TBI research. Therefore, we aimed to provide an overview of health-care utilization, and of six-month out- comes after TBI and their determinants in older adults who sustained a TBI. Methods: We used data from the prospective multi-center Collaborative European NeuroTrauma Effective- ness Research in Traumatic Brain Injury (CENTER-TBI) study. In-hospital and post-hospital health care uti- lization and outcomes were described for patients aged ?65 years. Ordinal and linear regression analyses were performed to identify determinants of the Glasgow Outcome Scale Extended (GOSE), health-related quality of life (HRQoL), and mental health symptoms six-months post-injury. Results: Of 1254 older patients, 45% were admitted to an ICU with a mean length of stay of 9 days. Nearly 30% of the patients received inpatient rehabilitation. In total, 554/1254 older patients completed the six- month follow-up questionnaires. The mortality rate was 9% after mild and 60% after moderate/severe TBI, and full recovery based on GOSE was reported for 44% of patients after mild and 6% after moderate/severe TBI. Higher age and increased injury severity were primarily associated with functional impairment, while pre-injury systemic disease, psychiatric conditions and lower educational level were associated with func- tional impairment, lower generic and disease-specific HRQoL and mental health symptoms. Conclusion: The rate of impairment and disability following TBI in older adults is substantial, and poorer outcomes across domains are associated with worse preinjury health. Nonetheless, a considerable number of patients fully or partially returns to their preinjury functioning. There should not be pessimism about outcomes in older adults who survive
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Traumatic Brain Injury Older adults Outcomes Health care utilization Health-related quality of life Mental health
Megjelenés:	Injury-International Journal Of The Care Of The Injured. - 53 : 8 (2022), p. 2774-2782. -
További szerzők:	Mikolić, Ana Lee Hee, Quentin Kaplan, Z. L. Rana Retel Helmrich, Isabel R. A. van Veen, Ernest Andelic, Nada von Steinbuechel, Nicole Plass, Anne Marie Zeldovich, Marina Wilson, Lindsay Maas, Andrew I. R. Haagsma, Juanita A. Polinder, Suzanne Sándor János (1966-) (orvos-epidemiológus) CENTER-TBI Participants and Investigators
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001-es BibID:	BIBFORM107421
035-os BibID:	(scopus)85117210103 (wos)000681565200001
Első szerző:	van Veen, Ernest
Cím:	Occurrence and timing of withdrawal of life-sustaining measures in traumatic brain injury patients : a CENTER-TBI study / van Veen Ernest, van der Jagt Mathieu, Citerio Giuseppe, Stocchetti Nino, Gommers Diederik, Burdorf Alex, Menon David K., Maas Andrew I. R., Kompanje Erwin J. O., Lingsma Hester F., CENTER-TBI investigators and participants
Dátum:	2021
ISSN:	0342-4642
Megjegyzések:	Background: In patients with severe brain injury, withdrawal of life-sustaining measures (WLSM) is common in inten sive care units (ICU). WLSM constitutes a dilemma: instituting WLSM too early could result in death despite the pos sibility of an acceptable functional outcome, whereas delaying WLSM could unnecessarily burden patients, families, clinicians, and hospital resources. We aimed to describe the occurrence and timing of WLSM, and factors associated with timing of WLSM in European ICUs in patients with traumatic brain injury (TBI). Methods: The CENTER-TBI Study is a prospective multi-center cohort study. For the current study, patients with traumatic brain injury (TBI) admitted to the ICU and aged 16 or older were included. Occurrence and timing of WLSM were documented. For the analyses, we dichotomized timing of WLSM in early (<72 h after injury) versus later (?72 h after injury) based on recent guideline recommendations. We assessed factors associated with initiating WLSM early versus later, including geographic region, center, patient, injury, and treatment characteristics with univariable and multivariable (mixed efects) logistic regression. Results: A total of 2022 patients aged 16 or older were admitted to the ICU. ICU mortality was 13% (n=267). Of these, 229 (86%) patients died after WLSM, and were included in the analyses. The occurrence of WLSM varied between regions ranging from 0% in Eastern Europe to 96% in Northern Europe. In 51% of the patients, WLSM was early. Patients in the early WLSM group had a lower maximum therapy intensity level (TIL) score than patients in the later WLSM group (median of 5 versus 10) The strongest independent variables associated with early WLSM were one unreactive pupil (odds ratio (OR) 4.0, 95% confdence interval (CI) 1.3?12.4) or two unreactive pupils (OR 5.8, CI 2.6?13.1) compared to two reactive pupils, and an Injury Severity Score (ISS) if over 41 (OR per point above 41=1.1, CI 1.0?1.1). Timing of WLSM was not signifcantly associated with region or center. Conclusion: WLSM occurs early in half of the patients, mostly in patients with severe TBI afecting brainstem refexes who were severely injured. We found no regional or center infuences in timing of WLSM. Whether WLSM is always appropriate or may contribute to a self-fulflling prophecy requires further research and argues for reluctance to insti tute WLSM early in case of any doubt on prognosis.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk traumatic brain injury
Megjelenés:	Intensive Care Medicine. - 47 : 10 (2021), p. 1115-1129. -
További szerzők:	van der Jagt, Mathieu Citerio, Giuseppe Stocchetti, Nino Gommers, Diederik Burdorf, Alex Menon, David Krishna Maas, Andrew I. R. Kompanje, Erwin J. O. Lingsma, Hester Sándor János (1966-) (orvos-epidemiológus) CENTER-TBI Participants and Investigators
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001-es BibID:	BIBFORM107438
035-os BibID:	(scopus)85085505275 (wos)000581019400002
Első szerző:	van Wijk, Roel P. J.
Cím:	Informed consent procedures in patients with an acute inability to provide informed consent : Policy and practice in the CENTER-TBI study / van Wijk Roel P. J., van Dijck Jeroen T. J. M., Timmers Marjolein, van Veen Ernest, Citerio Giuseppe, Lingsma Hester F., Maas Andrew I. R., Menon David K., Peul Wilco C., Stocchetti Nino, Kompanje Erwin J. O., CENTER-TBI investigators and participants
Dátum:	2020
ISSN:	0883-9441
Megjegyzések:	Purpose: Enrolling traumatic brain injury (TBI) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and prac- tice. Methods: Variation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries. Results: Variation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N = 426;20%) and deferred consent (N = 334;16%). Deferred consent was only ac- tively used in 15 centres (26%), although it was considered valid in 47 centres (82%). Conclusions: Alternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of dif- ferent informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Traumatic brain injury Informed consent European Union Ethics
Megjelenés:	Journal Of Critical Care. - 59 (2020), p. 6-15. -
További szerzők:	van Dijck, Jeroen T. J. M. Timmers, Marjolein van Veen, Ernest Citerio, Giuseppe Lingsma, Hester Maas, Andrew I. R. Menon, David Krishna Peul, Wilco C. Stocchetti, Nino Kompanje, Erwin J. O. Sándor János (1966-) (orvos-epidemiológus) CENTER-TBI Participants and Investigators
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